MR Assessment of Perianal Crohn's Disease

NCT03325582 | Unknown

• 1 other identifier: 211758
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

Perianal Crohn's disease (pCD) is the commonest form of fistulising Crohn's disease, with up to 38% of patients affected and with 30% of them experiencing recurring disease symptoms. Presence of fistula can lead to major morbidity due to cutaneous perianal abscess formation or drainage. To date, it is very difficult to quantify inflammation in patients with pCD due to the absence of reliable disease activity measurements. In addition to this, optimising therapies for pCD is quite challenging and may have a major impact on quality of life. Magnetic resonance imaging of pelvic is a standard examination for the anatomical evaluation of pCD which is significant in terms of surgical therapy and progress. The overall hypothesis is that newer MRI techniques such as magnetization transfer (MT), diffusion weighted image ( DWI) and dynamic contract enhancement (DCE) are better suited to measuring the inflammatory vs fibrotic burden in pCD. The aim of this project is to measure disease activity within pCD and luminal CD using MRI sequences before and after biological therapy

Conditions

Perianal Fistula

Keywords

Perianal Fistula Crohn's disease, MRI

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  1\. The difference in the composite MR endpoints between the change in novel MRI parameter (c-f) and the change in standard of care MRI (a-b) from baseline in responders to biological therapy at 12 weeks post-treatment onset at 3T and 1.5T. 1. The number, course and extension of fistulas with active inflammation in the fistula quantified through hypersensitivity in T2-weighted images, rectal wall involvement and presence of abscesses (Van Assche Score) 2. Gadolinium-mediated T1 enhancement. 3. Quantitative dynamic contrast enhancement, 4. Magnetisation transfer and T2 signals 5. Fistula volume 6. Apparent diffusion coefficient in diffusion-weighted MR images

  At 12 week

Secondary Outcomes (1)

• Secondary Outcome measure

  At 12 weeks

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients between 16 to 75 years (Adult)

You may qualify if:

• Active perianal Crohn's disease as defined by clinical assessment and a PDAI score of \>4.
• A clinical decision has been taken to start biological therapy
• Ages of 16-75
• No immediate plan for surgery in the near future
• Ability to consent
• No obvious contraindication to the use of MR
• A clear intention by the recruited participant to adhere to the study protocol.

You may not qualify if:

• Immediate surgery planned on the perianal Crohn's disease in the following 12 weeks.
• Inability to consent
• history of proctectomy,
• absence of a diagnosis of Crohn's disease,
• perianal fistulising disease not secondary to Crohn's disease,
• rectovaginal fistulas
• Malignant disease
• Significant cardiovascular or respiratory disease
• Neurological or cognitive impairment
• Significant physical disability
• Significant hepatic disease or renal failure
• Abnormal blood results other than those explained by CD
• Participants currently (or in the last three months) participating in another research project
• pregnancy or breastfeeding
• If MRI is contraindicated (e.g. pacemaker

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (3)

St Mark's Hospital and London North West Healthcare NHS Trust

London, United Kingdom

ACTIVE NOT RECRUITING

University of Manchester Institute of Inflammation and Repair Clinical Sciences Building, Salford Royal NHS Trust, Salford

Manchester, M6 8HD, United Kingdom

ACTIVE NOT RECRUITING

Nottingham Digestive Diseases Centre, QMC Campus, Nottingham University Hospitals

Nottingham, NG7 2UH, United Kingdom

RECRUITING

Study Officials

• Gordon Moran, PhD,MD

  The university of Nottingham, Faculty of Medicine & Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gordon Moran, PhD,MD

CONTACT

+44 (0)115 9249924; Gordon.Moran@nottingham.ac.uk

Jill Garratt, Nurse

CONTACT

+44(0)115 924 9924; jill.garratt@nuh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 30, 2017
• Study Start: April 21, 2017
• Primary Completion: December 30, 2018
• Study Completion: February 1, 2019
• Last Updated: October 11, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)